Effect of Aloe Vera Gel and Manuka Honey on Radiation Induced Oral Mucositis

NCT06381635 | Recruiting DMC

• 1 other identifier: FD-BUE-REC: IRB000124920
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this \[ type of study: Clinical trial\] is to test effectiveness of Aloe Vera Gel and Manuka Honey in management of Radiation Induced Mucositis in head and neck cancer patients. The main question \[s\] \] is to \[ learn about, test, compare etc.\] it aims to answer are:

1. 1.Is Aloe Vera Gel and Manuka Honey effective in management of Radiation Induced Mucositis?
2. 2.Does Aloe Vera Gel and Manuka Honey affect the level of TGFβ1 and EGF in saliva of patients with radiation induced mucositis? participants will be asked to apply Aloe Vera Gel and Manuka Honey or saline three times daily during radiotherapy and 6 months after radiotherapy.

Conditions

Radiation Mucositis

Outcome Measures

Primary Outcomes (1)

• Change from World Health Organization Oral Toxicity Scale Grading of Oral Mucositis

  World Health Organization Oral Toxicity Scale Grading of Oral Mucositis ranges from "1,2,3,4) the grade1 me

  Three points: -"baseline which is at the starting of radiotherapy", -"the second of the radiotherapy is at seventh week of the radiotherapy or 4-5 weeks from baseline, while the end point is after six months of radiotherapy.

Secondary Outcomes (2)

• the level of salivary transforming growth factor beta 1

  Two points: -"baseline which is at the second week of radiotherapy" while -"the end of the radiotherapy is at seventh week of the radiotherapy or 4-5 weeks from baseline.

• the level of salivary Epidermal Growth factor (EGF)

  Two points: -"baseline which is at the second week of radiotherapy" while -"the end of the radiotherapy is at seventh week of the radiotherapy or 4-5 weeks from baseline.

Study Arms (2)

intervention group

EXPERIMENTAL

patients will be given 20 mL of Manuka honey with aloe vera gel, 15 min before and after the radiotherapy. They were instructed to swallow slowly to smear the layer of honey on the oral and pharyngeal mucosa. Patients were also advised to take 20 mL of Manuka honey before sleeping in the night. This treatment protocol was followed from day 1 of radiation till 6 weeks.

Dietary Supplement: Manuka honey mixed with aloe vera gel

Control group

PLACEBO COMPARATOR

patients will be given 20 mL of 0.9% of saline 15 min before and after radiotherapy \[54\]. They will be advised to rinse saline. They will be instructed to keep saline for at least 5 min duration and then to spit it out. They will be advised to rinse 20 mL of saline in the same manner before sleeping. This treatment protocol was followed from day 1 of radiation till 6 weeks.

Dietary Supplement: Manuka honey mixed with aloe vera gel

Interventions

Manuka honey mixed with aloe vera gel DIETARY_SUPPLEMENT

a mix gel of manuka honey and with aloe vera honey (1:1) mixed in water bath to get a homogenous mix is then packed in unmarked bottles.

Control group; intervention group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a) Patients with a confirmed histologic diagnosis of H\&N malignancy who are referred to non-palliative radiotherapy in the oral cavity.
• b) Patient who is receiving radiation therapy with IMRT or 3D techniques. c) Patients received 50-70 Gy of total radiation at the rate of 2 Gy/fraction daily and 5 fractions/week.
• d) Patient who received concurrent chemotherapy with radiotherapy e) Presence of Oral Mucositis f) Age 20-70 years old g) Willing to participate in the study. h) Able to complete the study assessments.

You may not qualify if:

• a) Have a confirmed or medically treated diabetes mellitus b) Radiotherapy within the last 6 months prior to this study c) Vulnerable patients

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

ain shams University

Cairo, 11565, Egypt

RECRUITING

Fatma E.Sayed

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Aloe vera gel

Study Officials

• Fatma E. Hassanein, PHD

  lecturer

  STUDY DIRECTOR

Central Study Contacts

Fatma E. Hassanein

CONTACT

+201000093885; fatmahassanein@dent.asu.edu.eg

Asma A. Abou Bakr, PHD

CONTACT

Asmaa.Aboubakr@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 24, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)